With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether can find one way to relief the postoperative pain after such operation is still unknown. We hypothesized that the pain from the relatively small surgery may not be significant compared with different treatments, even...
Date First Received: August 21, 2007
Last Updated: April 18, 2008
Verified by: Nanjing Medical University, April 2008
Clinical Trial Phase: Phase 4 | Start Date: February 2007
Overall Status: Completed
Estimated Enrollment: 2000
Brief Summary
Official Title: “Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy”
Condition Keyword(s):
Intervention(s):
With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether can find one way to relief the postoperative pain after such operation is still unknown. We hypothesized that the pain from the relatively small surgery may not be significant compared with different treatments, even no drug was delivered to them.So then we are enrolling patients who underwent mastectomy from benign breast tumor, and observing the analgesic effects of different drugs.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Visual analog scale (VAS) rating of pain 0-24h after surgeries Yes
Secondary:
- VAS rating of sedation 0h to 24h after the end of the operation Yes
- Overall VAS rating of satisfaction with analgesia At the end of the study Yes
- Incidence of side effects From the initiation of analgesia to the end of the study Yes
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Chinese
- No cardiac and pulmonary diseases
- ASA I-II
- No alcohol drinking.
Exclusion Criteria:
- <19yrs, and >65yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
- Any other chronic diseases.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Nanjing Medical University
Nanjing Maternal and Child Care Hospital
Nanjing Jiangsu 210004 China
Overall Clinical Trial Officials and Contacts
XiaoFeng Shen, MD Study Chair Nanjing Medical University
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00519246
Study ID Number: NMU-2579-4FW
ClinicalTrials.gov Identifier: NCT00519246
Health Authority: China: Ministry of Health
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
